EP3340095B1 - Système d'assistance respiratoire et procédé - Google Patents

Système d'assistance respiratoire et procédé Download PDF

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Publication number
EP3340095B1
EP3340095B1 EP17002040.8A EP17002040A EP3340095B1 EP 3340095 B1 EP3340095 B1 EP 3340095B1 EP 17002040 A EP17002040 A EP 17002040A EP 3340095 B1 EP3340095 B1 EP 3340095B1
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EP
European Patent Office
Prior art keywords
user
authorization code
ventilator
remote station
data
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EP17002040.8A
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German (de)
English (en)
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EP3340095A1 (fr
Inventor
Matthias Schwaibold
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Loewenstein Medical Technology SA
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Loewenstein Medical Technology SA
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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/30—Authentication, i.e. establishing the identity or authorisation of security principals
    • G06F21/31—User authentication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/0816—Measuring devices for examining respiratory frequency
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/30—Authentication, i.e. establishing the identity or authorisation of security principals
    • G06F21/31—User authentication
    • G06F21/36—User authentication by graphic or iconic representation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/30—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L63/00—Network architectures or network communication protocols for network security
    • H04L63/08—Network architectures or network communication protocols for network security for authentication of entities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0026—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the transmission medium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/087—Measuring breath flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/30—Authentication, i.e. establishing the identity or authorisation of security principals
    • G06F21/31—User authentication
    • G06F21/32—User authentication using biometric data, e.g. fingerprints, iris scans or voiceprints
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/30—Authentication, i.e. establishing the identity or authorisation of security principals
    • G06F21/31—User authentication
    • G06F21/34—User authentication involving the use of external additional devices, e.g. dongles or smart cards
    • G06F21/35—User authentication involving the use of external additional devices, e.g. dongles or smart cards communicating wirelessly

Definitions

  • the present invention relates to a method for operating at least one data processing device of a ventilation system and a ventilation system with at least one data processing device.
  • the ventilation system comprises at least one respirator and at least one remote station that is spatially separated from the respirator. Therapy data is transmitted between the ventilator and the remote site using the data processing device.
  • Ventilation devices or sleep therapy devices generally have a storage device in order to be able to store and call up therapy data. So z. B. the ventilation parameters necessary for the therapy of a specific breathing disorder are stored. Data that characterize the course of therapy are often also stored.
  • Such data are particularly helpful in order to assess the success of the therapy or to support a specific diagnosis.
  • the data also provides information as to whether the user is using the ventilator correctly and regularly. In order to be able to guarantee a reliable diagnosis and an effective therapy, a regular or as frequent as possible assessment of the therapy data is therefore particularly important.
  • Ventilators have therefore become known, the memory of which can be accessed from outside, so that no visits are necessary to examine the therapy data. This is particularly advantageous in the case of ventilation systems with multiple ventilation devices or patients.
  • the stored data can be accessed as soon as there is a remote station with suitable software that can interpret the data.
  • suitable software that can interpret the data.
  • the serial number of the device must also be specified in order to be able to access it from the remote site. This is to ensure that the device with the entered serial number is local to the user. However, this still does not ensure that there is no input error or that the user wants to gain access to a device to which he is not authorized.
  • some ventilators sometimes have a second number printed on the device as a device code.
  • Device access can only be set up if the serial number and device code are entered correctly together.
  • this solution also has considerable disadvantages. People who had the device in front of them at an earlier time could have noted or photographed the device code. People who have the device in front of them at a later point in time can also gain access unnoticed, whether they are legitimate or not.
  • the method according to the invention serves to operate at least one data processing device of at least one ventilation system.
  • the ventilation system comprises at least one respirator and at least one remote station that is spatially separated from the respirator.
  • Therapy data can be at least partially transmitted between the ventilator and the remote site using the data processing device.
  • At least one authorization code is stored in the data processing device by at least one user of the ventilation system in order to obtain authorized access to the therapy data via the remote station.
  • the authorization code is only made available to the user when the user requests the authorization code by at least one user action to be carried out with respect to the data processing device and in particular with respect to the ventilation device and / or the remote station.
  • the creation by the remote site requires, in particular, that the user has at least one legitimate user account with the remote site and in particular authenticates himself there beforehand.
  • the authorization code provided preferably identifies the user uniquely.
  • the method according to the invention offers many advantages.
  • a significant advantage is that the authorization code is only made available to the user when the user requests it and does at least one user action. This enables considerably reliable access to the therapy data in terms of data protection and data security. So is the authorization code from the outside not visible on the device before the device is put into operation and the authorization code is requested.
  • the user is given access to the ventilator and preferably to the therapy data stored there on the basis of the authorization code.
  • the user can view and / or edit therapy data stored on the ventilator from the remote site, for example evaluate, change, copy and / or move.
  • access to the therapy data is not possible without authorization.
  • access to the therapy data is only possible if the authorization code provided is used.
  • direct access to the therapy data stored on the ventilator can be provided, for example.
  • the therapy data can also at least temporarily in the remote station and z. B. be stored on a server so that the therapy data of the ventilator can be accessed indirectly via the remote station.
  • the authorization code can be stored in the data processing device at least partially manually by the user, e.g. B. by entering at least one user interface or user interface and / or by connecting and / or inserting a data carrier on the ventilator that contains the authorization code. It is also possible that the authorization code is stored at least partially automatically, for example by at least one network transmission of the authorization code to the respirator and / or the remote station and / or by at least one generation by at least one algorithm in the respirator. In particular, the data processing device with the ventilator and the remote station, so that the authorization code can be stored in the data processing device by storing the authorization code in the ventilator and / or the remote station.
  • the authorization code cannot be viewed by the user without the request made by the user action.
  • the authorization code is not visible from outside the ventilator and in particular is not printed on the ventilator.
  • the data processing device is operatively connected to the ventilator and the remote station, so that a user cation performed with respect to the ventilator or the remote station is also performed with respect to the data processing device.
  • the user action is particularly preferably carried out at least partially with the ventilator.
  • the authorization code only authorizes access to therapy data of the respirator with which the user action is carried out. This can ensure, for example, that the user can only access the respirators of the ventilation system with which they actually use.
  • the authorization code is at least partially assigned to the ventilator. The assignment takes place, for example, via a serial number and / or a device identification number or the like.
  • the authorization code can be assigned to the user.
  • the authorization code authorizes only access to a specific ventilator and / or to only a single ventilator.
  • the authorization code also authorizes access to further ventilation devices of the ventilation system.
  • certain ventilators are assigned to a group, the authorization code authorizing access to the ventilators in the group. This is of great advantage for operators of larger ventilation systems, for example.
  • the user action includes in particular at least one start-up of the ventilator.
  • the user action preferably comprises at least one input into the ventilator.
  • the ventilator preferably has at least one user interface.
  • the input can include, for example, the selection of a device function that starts the output or generation of the authorization code. For example, menu entry and / or text entry can be provided. It is also possible for the user action to include at least partially in relation to the remote site and in particular at least one input into a user interface of the remote site.
  • the user action can include at least one biometric detection of the user and / or at least one voice command and / or at least one coupling of the ventilator to at least one storage medium.
  • the biometric detection can comprise, for example, at least one detection of at least one fingerprint and / or at least one iris structure.
  • at least one transportable or removable storage medium is coupled to the ventilator.
  • At least one computer or smartphone, tablet computer or the like can also be used. by cable or wireless, e.g. B. WIFI, Bluetooth etc. can be coupled with the ventilator.
  • the storage medium comprises at least one specific data record, for example a certificate, by means of which the authorization code is generated and / or called up.
  • the requested authorization code is sent to the user on at least one Display device, especially the ventilator, is displayed.
  • the display device comprises, for example, a display or is designed as such. In this way it can be reliably achieved that the ventilator is also in front of the intended user when the access is set up.
  • the requested authorization code is also possible for the requested authorization code to be stored on at least one, in particular removable, storage medium. This allows the user to store the authorization code on the remote terminal in a particularly convenient manner and input errors are avoided.
  • the user action preferably comprises at least one registration of the user with respect to the data processing device and particularly preferably with respect to the remote station.
  • the authorization code can in particular only be requested by a registered user.
  • Such a registration achieves a particularly high level of data security and data protection.
  • At least one authentication of the user to the data processing device takes place within the framework of the registration. It is also possible for the user to be authorized during registration. Authorization specifies, in particular, the access rights to certain therapy data for an individual user.
  • the data processing device can preferably manage at least two authorization codes from two different users, who can have different access rights.
  • At least one user account is set up when registering in the remote site. In particular, it also determines what type of access rights the user receives. For example, a user account for a caregiver or provider can offer broader access to therapy data than a user account for a patient.
  • the user action comprises at least one further step in order to be able to request the authorization code. It is also possible, however, that the registration is already the user action, so that the authorization code is requested at the same time as the registration.
  • the user When registering, the user is preferably assigned at least one certificate.
  • the certificate must be presented to the ventilator in order to request the authorization code. It is also possible that the certificate must be presented to the remote site in order to be able to request the authorization code. In this way, it can be ensured in a particularly reliable manner that only a specific user requests the authorization code.
  • the certificate includes user identification.
  • the certificate includes a determination of the access rights of the user and / or an authorization of the user.
  • the certificate has a time-limited validity and / or a one-time validity. It is also possible that the validity of the certificate is linked to the user. This has the advantage that, for example, if a storage medium with a certificate stored on it is lost, the certificate can be declared invalid, so that misuse of the lost storage medium is prevented.
  • the certificate preferably includes an assignment of the user to a user group.
  • the certificate preferably includes an assignment of the user to a user group.
  • everyone User group provided a certain authorization.
  • doctors or caregivers, providers and patients are assigned to different user groups with different authorizations.
  • the ventilator can use the certificate to recognize how far the respective user can be granted access rights.
  • the certificate is particularly preferably stored by the remote station on a transportable storage medium.
  • the authorization code can preferably only be requested if the respirator is coupled to the storage medium and in particular has access to the storage medium.
  • the certificate is stored on the storage medium when the user registers with a server via the remote station.
  • the user can take the storage medium to the ventilator and insert it there.
  • the ventilator preferably recognizes the user and in particular also his authorization and preferably outputs a suitable authorization code or transmits the authorization code or the certificate back to the remote station, which in particular checks the validity and identifies the user.
  • the certificate can comprise at least one device certificate identifying the respirator and / or at least one user certificate identifying the user or can be designed as such.
  • the remote station also preferably stores at least one uniquely identifying device certificate on the storage medium.
  • the certificate is designed in particular as a user certificate.
  • the device certificate is read in by the ventilation system and preferably transmitted back to the remote station. This enables the remote site to check that it is really a legitimate ventilation system and not an imitation that wants to send data to the remote site in order to store falsified, invalid or invented therapy data.
  • a non-transportable or permanently installed storage medium is provided. Then, for example, a network connection is established between the storage medium with the certificate and the ventilator in order to be able to request the authorization code.
  • the authorization code is particularly preferably generated at least partially by the ventilator, including the certificate. This has the advantage that a user and, for example, his group membership or authorization can be identified on the basis of the authorization code. It is also possible for the authorization code to be generated at least in part by the remote station, including the certificate.
  • the authorization code comprises at least part of the certificate and / or at least part of a device code of the ventilator.
  • the device code includes, for example, at least one serial number and / or at least one device identification number.
  • the ventilator can also be identified particularly well when it logs on with the authorization code. It is also possible to generate the authorization code independently of the certificate.
  • access to the therapy data is released when the registered user logs on to the remote station after having previously requested the authorization code as a registered user Has. It is particularly preferred that the user has previously requested the authorization code by presenting the certificate. Such a configuration is particularly secure and at the same time very convenient since the user does not have to enter the authorization code in the remote site.
  • the authorization code is transmitted from the ventilator to the remote station via at least one network connection or wireless data connection.
  • the transmission takes place in particular automatically when a registered and preferably certified user requests the authorization code.
  • access to the therapy data is only released when the user informs the authorization code made available to him of the data processing device and in particular of the remote station. In this way, it can be ensured in a particularly reliable manner that the person who wants to access the therapy data from the remote site is also the person who visited the ventilator and requested the authorization code there.
  • the data processing device preferably compares the authorization code communicated by the user with a generated and / or stored authorization code. In particular, access to the therapy data is only released if the comparison shows a suitable match.
  • the authorization code is entered by the user in the remote station.
  • the user communicates the authorization code made available to the remote station so that access to the therapy data can be released.
  • the user notes the authorization code while he is with the patient on the ventilator. Then he builds on his Connect to the remote station and enter the authorization code there.
  • the authorization code can be entered via at least one speech recognition.
  • the transmission of the authorization code can also include at least one other manual step, for example the transport of the authorization code stored on a storage medium from the ventilator to the remote station.
  • the entry can also be made by the user coupling the remote station to at least one storage medium on which he has stored the authorization code.
  • optically enter the authorization code for example as a QR code, which is in particular read out with the aid of a camera and is evaluated later, or the like.
  • the ventilator transmits the authorization code at least partially independently to the remote site. Independent transmission is particularly preferred if the ventilator generates the authorization code at least in part on the basis of a certificate. In this way, it can be reliably ensured that transmission is only carried out by an authorized user.
  • the authorization code comprises at least one serial number and / or at least one device identification number of the ventilator. It is also possible that the authorization code is at least partially generated from a serial number and / or device identification number.
  • the authorization code includes in particular at least one number and / or at least one letter and / or special characters.
  • the authorization code preferably comprises at least a sequence of at least four characters or more.
  • the authorization code can be generated at least partially randomly.
  • the authorization code can also include at least a defined sequence of sounds and / or gestures and / or movements.
  • the authorization code comprises at least one gesture and / or movement of at least one finger.
  • the authorization code can also include at least one fingerprint and / or at least one image of at least part of the iris and / or the retina of the user.
  • the authorization code comprises at least one test center.
  • the test center can be determined in particular on the basis of the serial number and / or device identification number of the ventilator and / or remaining digits of the authorization code. This has the advantage that the ventilator and / or the remote station can already check for input errors before the entire authorization code is transmitted to the respirator or the remote station.
  • the authorization code preferably comprises at least information about authorization of the user with regard to access to the therapy data.
  • the authorization code indicates whether the user is authorized to access all therapy data or only partial access.
  • the authorization code can assign the user to at least one user group. This can preferably be due to the integration of a user type in the authorization code, on the basis of which the remote station can manage the access rights.
  • the authorization code can include at least information about at least one read right and / or write right of the user.
  • Read and write rights are preferably assigned to a user during the registration of the user and particularly preferably on the basis of the certificate of the user.
  • the certificate includes at least one right to read and / or one right to write.
  • the data processing device or the respiratory system preferably also differentiates between read and write rights in the access rights.
  • Reading rights are required in particular in order to be able to read therapy data from the ventilation system at the remote site.
  • Write rights are required in particular in order to be able to change therapy data of the ventilation system at the remote site, e.g. B. the ventilation settings, in particular at least one ventilation pressure or a pressure limit, ventilation frequency or a humidification line.
  • write rights to the data processing device or to the ventilation system itself can in principle be blocked via the data processing device. This is done e.g. B. by a corresponding input on the user interface, a voice command or an input via cable or storage medium. This means a particularly high level of security. Is z. For example, if a remote adjustment of the ventilation system by legitimate users of the remote station is not to be carried out anyway, this prevents unauthorized users or unauthorized counterfeiting of the remote station from performing a remote adjustment.
  • the authorization code has at least a time-limited validity and / or a one-time validity.
  • the authorized access to the therapy data ends when the validity expires.
  • the authorization code can only be valid for one-time access. It is also possible that the authorization code is only valid to set up at least one access. The access set up can then also be valid in the long term, even if the authorization code itself is no longer valid.
  • the authorization code has a validity which is limited for the duration of an intended period of use of the ventilation system. This is particularly good at preventing unauthorized access to ventilators that are no longer used. In particular, at least one new authorization code must then be requested when changing patients.
  • the authorization code is preferably only valid for a specific user and in particular only for a registered user. It is also possible that the authorization code is valid for a plurality of users and for example for a user group.
  • the validity of the authorization code is linked to the user.
  • the validity of the authorization code is preferably linked to the authorization of the user.
  • the coupling takes place in particular by assigning the authorization code to a registration or to a user certificate. For example, it is possible that an authorization code expires if the authorization of the user is restricted and / or expanded. This ensures that the access rights that are released by the authorization code also correspond to the authorization of the user. This can prevent confidential therapy data from being viewed by users who are only allowed to access general data.
  • the validity of the authorization code and, in particular, of the access, at least for certain users, is particularly preferably canceled when the ventilator is used for a new patient.
  • the data processing device monitors at least one characteristic parameter for assigning the ventilator to a patient.
  • This parameter can for example, a patient name and / or a patient address.
  • the authorization code then loses its validity or has to be renewed if such a parameter is changed.
  • a change of patient can preferably also be recognized indirectly by the remote station and the ventilation system, e.g. B. when deleting the therapy data in the ventilator or a longer break in the use of the ventilator, preferably more than a week.
  • the authorization code which is requested by the user is preferably at least partially stored in the ventilator and / or is at least partially generated by the ventilator.
  • at least one logic and / or at least one algorithm is stored in the ventilator.
  • the remote station is also suitable and designed to generate the same authorization code so that a comparison is possible.
  • the same logic or the same algorithm is stored both in the remote station and in the ventilator.
  • the same authorization code can also be stored in the remote site to enable a comparison.
  • the authorization code can also be sent from the ventilator to the remote site over a network connection to allow synchronization.
  • the authorization code that is requested by the user is generated spatially separate from the respirator and preferably in the remote station and / or is stored.
  • the authorization code can also be generated at least partially at a location that is spatially separated from the ventilation system and at least one code generator.
  • the data processing device and preferably the remote station are connected to a code generator via at least one network connection.
  • the Authorization code can then be transmitted to the ventilator, for example via a network connection or by transporting a storage medium or by programming during manufacture, e.g. B. on a test bench.
  • the ventilation system comprises at least one ventilation device with at least one ventilation device for generating at least one air flow for respiratory therapy.
  • the ventilation system comprises at least one remote station that is spatially separated from the ventilation device and at least one data processing device.
  • Therapy data can be transmitted between the ventilator and the remote station using the data processing device.
  • At least one authorization code can be stored in the data processing device in order to grant a user authorized access to the therapy data via the remote station.
  • the data processing device is suitable and designed to provide the user with the authorization code when the user requests the authorization code through at least one user action performed on the data processing device.
  • the ventilation system according to the invention also offers improved access to the therapy data, so that a high level of data security or data protection is achieved.
  • the ventilation system is particularly preferably suitable and designed to be operated by the method according to the invention.
  • the data processing device in particular comprises at least one user interface.
  • the user interface is particularly suitable and designed to receive at least one input from the user and to convert it into an electronically processed signal.
  • the user interface includes, for example, at least a human interface device. For example, at least one text input and / or voice input can be made via the user interface. A biometric detection of the user can also be carried out with the user interface.
  • the data processing device is particularly suitable and designed to connect the ventilator and the remote station to one another via at least one network connection.
  • the data processing device can be at least partially integrated in the respirator and / or the remote station, or at least partially provided by them.
  • the data processing device can at least partially include the ventilator and / or the remote station.
  • the data processing device is particularly suitable and designed to read out and / or write to at least one storage device of the ventilator and / or the remote station.
  • the remote station can be provided by at least one network device or comprise at least one.
  • the remote site comprises at least one server and / or at least one computer cloud.
  • the network connection uses in particular a wired connection and / or a mobile radio connection and / or the Internet, VPN, WLAN (Wireless Local Area Network) and / or LAN (Local Area Network).
  • Corresponding interfaces are preferably provided on the ventilator and the remote station for this purpose.
  • the Figure 1 shows a highly schematic representation of a ventilation system according to the invention.
  • a ventilation system 10 according to the invention is shown, which here comprises a ventilation device 1 used as a home ventilation device 11 or a sleep therapy device.
  • the ventilator 1 can also be designed as a clinical ventilator 1.
  • the respirator 1 is suitable and designed for carrying out the method according to the invention.
  • the ventilation device 1 comprises a ventilation device 100 with a blower device 101 for generating an air flow for ventilation.
  • a monitoring device 21 is provided here to control the ventilation device 100 and to record therapy data.
  • the ventilator 1 is operated and set via a user interface 61 with operating elements 103 and a display device 11.
  • the ventilator 1 has a breathing interface 102 in order to supply the air flow to a user for ventilation.
  • the breathing interface 102 shown here is a breathing mask 105 designed as a nasal mask.
  • a hood 106 is provided for fixing the breathing mask 105.
  • the breathing interface 102 can also be designed, for example, as a full-face mask, as a nasal pillow, as a tube or as a larynx mask.
  • a connecting hose 109 is provided which is connected to the ventilation device 100 by means of a coupling device 112.
  • the connecting hose 109 is connected to the breathing interface 102 via a coupling element 107.
  • An exhalation element 108 which comprises a valve, is arranged between the connecting hose 109 and the coupling element 107 or is designed as such.
  • the exhalation element 108 is in particular intended to prevent breathing back into the ventilator 1 while the user is exhaling.
  • the monitoring device 21 is here operatively connected to a sensor device, not shown, which has one or more sensors for detecting device parameters and / or patient parameters and / or other variables characteristic of ventilation.
  • the monitoring device 21 comprises a pressure sensor, not shown here, which detects the pressure conditions with respect to the breathing interface 102.
  • the pressure sensor is connected to the breathing interface 102 via a pressure measuring hose 110.
  • the pressure measuring hose 110 is connected to the monitoring device 21 via an inlet connection 111.
  • the monitoring device 21 is used to control the blower device 101.
  • the monitoring device 21 provides a necessary minimum pressure and compensates for pressure fluctuations which are caused by the breathing activity of the user.
  • the monitoring device 21 also detects the current pressure in the breathing mask 105 and adjusts the output of the blower device 101 accordingly until a desired ventilation pressure is present.
  • the device parameters required for setting the ventilation device 100 or the blower device 101 as well as the device configuration and / or device software are stored in a memory device 31.
  • monitoring device 21 can also be designed to record patient parameters.
  • monitoring device 21 can be equipped with sensors for measuring the breathing excursion, for measuring an oxygen saturation of the blood and / or for measuring an EEG, an EMG, an EOG or an EKG activity.
  • the respirator 1 shown here can be designed as a fixed-level device or as an automatic-level device.
  • the monitoring device 21 regulates the target device parameters, which have previously been individually calculated and determined on the basis of the characteristic breathing of a user.
  • the ventilation device 100 can be adapted dynamically and in particular depending on the breathing phase of the user. For example, a monitoring of a breathing phase change can be detected on the basis of the monitoring device 21, so that a higher or lower pressure can be provided depending on the breathing phase.
  • the ventilator 1 can be designed as a CPAP or APAP device.
  • the respirator 1 can also be designed as a bilevel device. For example, the ventilator 1 responds to certain breathing events, such as. B. snoring, flattening of the breath and / or obstructive pressure peaks with appropriate settings of the device parameters.
  • the pressure conditions detected by the monitoring device 21 are stored together with further device parameters in a storage device 31.
  • the pressure ratios set by the monitoring device 21 or the pressure adjustments made are likewise stored as device parameters in the storage device 31.
  • the recorded patient parameters can also be stored in the memory device 31.
  • data on compliance and mask tightness can be saved.
  • a start therapy pressure, a maximum therapy pressure, a minimum therapy pressure and / or a target volume and / or other device parameters suitable for setting the ventilation device 100 can be stored as device parameters. These device parameters are called up by the monitoring device 21 to set the ventilation device 100 from the storage device 31.
  • the pressure ratios and / or other device parameters and / or patient parameters recorded over the therapy period are stored in the memory device 31 as part of therapy courses.
  • courses of therapy z. B. a flow course, a pressure course and / or an event course can be registered.
  • the therapy courses are provided to the memory device 31 by the monitoring device 21, which records this data during the therapy.
  • the device parameters and / or patient parameters and / or therapy courses stored in the storage device 31 are called up and evaluated to form one or more therapy statistics.
  • the therapy statistics are stored in the storage device 31.
  • an average pressure and / or the duration of therapy and / or a leakage parameter can be determined and stored.
  • the therapy statistics can also be configured as statistics for one therapy period each, which comprises several therapy treatments.
  • the therapy statistics can also include an evaluation of the willingness of the user to cooperate.
  • the values and sizes stored in the memory device 31 as described above are referred to as therapy data or data in the context of the present invention.
  • a transmission of the therapy data to at least one remote station 3 by means of a data processing device 2 is provided here.
  • the data processing device 2 provides the components or software here so that the remote station 3 can interpret the data from the ventilator 1 and vice versa.
  • the ventilation system 10 can also comprise two or more remote stations 3, which are connected to one or more ventilation devices 1.
  • the transmission takes place by means of a transmission device 51 wirelessly and / or wired.
  • the transmission can take place via one or more cable interfaces, e.g. B. USB, serial, LAN, data bus etc.
  • the transmission can also take place via one or more wireless interfaces, eg. B. Mobile communications, LPWAN, Bluetooth, infrared, Sigfox, Lora etc.
  • the remote station 3 can comprise at least one server 13 and / or at least one personal computer (PC) 23 or can also be designed as a computer cloud or cloud. So z. B. can be accessed from a PC 23 on a web server 13, which in turn is connected via a network connection to one or more ventilators 1. The data exchange is monitored or controlled by the data processing device 2.
  • PC personal computer
  • the therapy data can also be stored at least partially on a transportable storage medium 41.
  • the storage medium 41 is designed, for example, as a memory card or a hard disk or a USB mass storage device.
  • the storage medium 41 can be removed from the device and a reader and z. B. a computer, tablet computer, smartphone etc. can be read out.
  • the therapy data can also be read out via a display 11 located in the device 1 and / or connected to the device 1 or a user interface 61.
  • device 1 can be equipped with new configuration data or new program code or functions in device 1 can be activated.
  • One or more data memories 31, 41 in the device 1 are therefore preferably written and / or read from the outside.
  • the therapy data can be accessed from the remote site 3 from a remote location, so that location-independent evaluation is possible. Doctors, providers, patients and others can thus access the data in the ventilation system 10. For data protection and data security reasons, access is preferably restricted to the devices 1 that are used by the user.
  • the patient receives e.g. B. only access to his device 1. Specialists such as providers and doctors get z. B. Access to devices 1 of all their patients.
  • Each user can set up access to his devices 1 himself. Or one of the users sets up the access and then forwards the authorizations to other users within the data processing device 2 or the ventilation system 10 and preferably the remote station 3. It must therefore be entered in the data processing device 2 that at least one user wants to or may access a specific device 1.
  • an authorization code In order to make data traffic particularly secure in terms of data protection and data security, access is only possible here using an authorization code.
  • the authorization code is only made available to the user when the user requests the authorization code. This allows the code e.g. B. not just of Unauthorized persons can be read on the outside of the device.
  • To request the authorization code at least one user action must be carried out in relation to the data processing device 2.
  • the authorization code is called up here e.g. B. on the display 11 or user interface 61 of the ventilator 1 or on an externally connected display or by voice output or on a removable storage medium 41.
  • the authorization code can only be called up on the device 1 in certain operating states of the device 1.
  • the operating state in which the authorization code is called up is established here by a user action. For example, pressing at least one button / rotary knob / touchscreen button on device 1 or a combination of buttons or other operating elements; Entering a voice command; Entering a storage medium 41 with a specific code, on the basis of which the device 1 establishes the operating state; Entering a command to the device 1 via one of the wired or wireless interfaces; Checking a fingerprint or image of a user's iris or retina.
  • the operating state is limited in time.
  • the authorization code cannot therefore be read or read from the device 1 for any length of time.
  • a preferred time limit is between 5 seconds and 5 minutes. Other periods are also possible.
  • the operating state can preferably be ended prematurely by the user.
  • the device 1 here comprises logic to generate or call up the authorization code on the basis of its serial number or device identification code.
  • the remote station 3, which reads device data, has the same logic of generating or calling up or display and can write data storage 31 of the device 1 from the outside. In this way, remote station 3 can check whether the authorization code is correct.
  • the authorization code can be generated by a code generator 12, which in turn communicates the authorization code to both the device 1 and the remote station 3.
  • the device 1 can thus output the correct authorization code and the remote station 3 can check the correctness of the authorization code.
  • the code generator 12 can e.g. B. include at least one random generator.
  • the code generator 12 is part of the ventilator 1.
  • the code generator 12 can also be part of the remote station 3.
  • the code generator 12 can also be connected to the ventilator 1 and the remote station 3 via a network connection, e.g. B. as shown in dashed lines here.
  • the respirator 1 particularly preferably only allows medical or technical data to be queried on a built-in or connected display unit 11 if the correct authorization code has been entered on the device 1.
  • the authorization code is particularly preferably transmitted in an encrypted or veiled manner during data communication between the remote station 3 and the ventilator 1.
  • a transmission from the remote station 3 to the ventilator 1 serves to enable the device 1 to output the correct authorization code if the remote station 3 should know the authorization code in front of the ventilator 1 in terms of time.
  • a transfer from The ventilator 1 towards the remote station 3 is used so that the remote station 3 can check the correct authorization code if the respirator 1 should know the authorization code in time in front of the remote station 3.
  • the user then enters the requested and provided authorization code at the remote station 3. This is done e.g. B. via controls 103 and / or via voice input and / or using a storage medium 41 that is coupled to the remote station 3.
  • the remote station 3 Only if there is a valid authorization code does the remote station 3 enable data communication or storage or display or modification of therapy data. This prevents data from the wrong device 1 from being displayed or changed by mistake or on purpose.
  • a notification is preferably sent, e.g. B. to other users or administrators of the remote station 3 or to the ventilator 1.
  • Access can be compared with a database of 'eligible' devices, e.g. B. with an ERP system. It is preferably checked whether a provider has purchased device 1.
  • the remote station 3 preferably differentiates between different users and enables communication or storage or display or modification of therapy data only for those users who have correctly entered or read the authorization code.
  • Authorization codes generated, for. B. are output in different operating states of the device 1 or communicated to different users by the code generator 12. Depending on the authorization code, the role of the user can thus be recognized and the access rights can be limited to a specific subset of the therapy data available.
  • a patient code and a distinguishable physician code and / or provider code can be provided.
  • accessing device data e.g. B. via a web server as remote station 3
  • the patient receives a subset of the stored data in a view specially prepared for him with explanations optimized for him.
  • he can only change certain configuration parameters of the ventilator 1 via the remote station 3, e.g. B. Comfort parameters.
  • the doctor code represents a different subset or the total amount of stored therapy data in a view specially prepared for doctors.
  • the doctor can also change therapeutically relevant configuration parameters via the remote station 3, e.g. B. at least one therapy pressure.
  • the authorization code is in particular only valid for a selection of ventilation devices 1, preferably only for a single device 1 with a specific serial number or device identification code.
  • the authorization code can change over time. This means that the ventilation device 1 has a large number of authorization codes or can be generated.
  • authorization codes For the current access to or from device 1 received therapy data, however, only a few of these authorization codes are valid, preferably only one. A previously noted code is then no longer valid. For example, with each patient or owner change, a new authorization code is generated by the device 1.
  • the time-varying code is e.g. B. created in the remote station 3 and transmitted to the device 1. This can reliably ensure that the device 1 is in front of the future user at the moment an access is set up or during the request for the authorization code.
  • an authorization code is valid for a longer period of time, which is ended by an event.
  • a new authorization code is then valid.
  • Possible events or parameters for changing the valid code can be: expiry of a defined validity period; Deleting device data; Assignment of the device 1 to a new patient; Assignment of device 1 to a new organization, e.g. B. Doctor or operator or homecare provider; Expiry of a defined period in which the data was not accessed; Access by a new or additional user to the device 1 or the data received by it; significant changes to the device 1, such as. B.
  • actions always requests a new authorization code in the form of a one-time code.
  • Such actions or parameters are, for example: assignment of a patient to a device 1; Changing configuration parameters of a device 1; Update the program code of a device 1; Reading out amounts of data that go beyond the regularly transmitted level and therefore cause increased transmission costs; Transmission of identifying therapy data; Assignment of a patient to an organization, e.g. B. attending doctor or provider; Delete data or patient records.
  • the ventilator 1 is only able to generate or receive authorization codes or to save or output them by updating the program code.
  • a code e.g. a certificate
  • a code that is permanently stored in the counterpart 3 e.g. a further certificate
  • the ventilator 1 and counterpart 3 are really authentic products and not replicas to bypass or listen to the authorization code.
  • they check each other's certificates or both communicate with an additional test center, e.g. B. a certificate server that the authenticity of the certificates approved.
  • the user action comprises at least one registration of the user with respect to the remote station 3.
  • the authorization code can only be requested by a registered user.
  • the user is directed z. B. first a secured account on a server 13 provided, with which he authenticates. If the user is logged on to the server 13, he can create a storage medium 41 or data carrier (eg an SD card) with data that uniquely identify him as a user. For this purpose, the server 13 stores a user certificate on the storage medium 41, which thereby becomes a "key card".
  • the certificate consists in particular of at least one code that identifies the user and z. B. is secured by a checksum.
  • the certificate or code can contain further information.
  • an attribute of the user group Is the user a doctor, patient or provider?
  • the certificate can also have at least one unique code, so that a key card z. B. declared invalid when lost to the server 13 and a new, distinguishable key card can be generated.
  • the certificate can contain at least one attribute as to whether the key card should only be valid for one device 1 or permanently.
  • the certificate can include at least one server address or a dial-in address on the Internet that leads exactly to the database to which the respective owner of the key card has his account.
  • the user inserts the key card at the patient's Commissioning or the moment of tele-initiation into the ventilator 1.
  • the ventilator 1 recognizes the user certificate on the key card and sends a message to the remote station 3 or the server.
  • This message includes at least part of the user certificate that identifies the user and a code that identifies the device, e.g. B. a serial number and / or a device identification number.
  • the server checks the validity of both identities (user certificate and device identification). If both are valid, device 1 and user are associated with each other without any code having to be entered manually. The next time the user logs in, the user finds the device 1 on the remote station 3 or on the server and can view the therapy data of the device 1 or assign a patient to the device 1.
  • other users or other remote sites 3 can also access the device 1. Either automatically, e.g. B. a user group to which the user belongs who has inserted the key card into the device 1, or other users, e.g. B. Doctors that the original user manually selects for the patient.
  • the device 1 preferably decides on the basis of the attributes of the user certificate whether it subsequently deletes or invalidates it or leaves it unchanged for further devices on the key card.
  • the user can also be the patient who wants to view his own therapy data via the remote station 3 or on the server 13. He can also activate access to the data of his device 1 via a key card.
  • the data processing device 2 or the server 13 of the remote station 3 preferably decides whether it is triggered due to a certain event, a new certificate is required, especially from the patient.
  • events that indicate a change of patient are taken into account.
  • Such events can e.g. B. can be recognized on the basis of characteristic parameters.
  • Such parameters are e.g. B. Therapy data deleted in device 1, prolonged non-use of device 1, an assignment of device 1 on the server to a new patient.
  • the invention presented here enables particularly secure access to therapy data and offers reliable protection against confusion and that the wrong device 1 is read out or written to. It also offers protection against people deliberately gaining access to reading or writing to ventilators 1 for which they have no authorization. It can also be counteracted effectively that every person can access all therapy data of a respirator 1, even if they only have authorization or the necessary knowledge for some of the data.

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Claims (19)

  1. Procédé d'exploitation d'au moins un dispositif de traitement de données (2) d'un système de ventilation (10) avec au moins un respirateur (1) et avec au moins un poste terminal (3) séparé spatialement du respirateur (1), dans lequel le dispositif de traitement de données (2) permet de transmettre au moins en partie des données thérapeutiques entre le respirateur (1) et le poste terminal (3) et dans lequel au moins un code d'autorisation est enregistré dans le dispositif de traitement de données (2) par au moins un utilisateur du système de ventilation (10) pour obtenir un accès autorisé aux données thérapeutiques via le poste terminal (3), et dans lequel le code d'autorisation n'est mis à la disposition de l'utilisateur qu'à partir du moment où ce dernier sollicite le code d'autorisation par au moins une action de l'utilisateur à accomplir auprès du dispositif de traitement de données (2).
  2. Procédé selon la revendication précédente, dans lequel l'action de l'utilisateur est exécutée au moins en partie avec le respirateur (1) et dans lequel le code d'autorisation n'habilite qu'à accéder aux données thérapeutiques du respirateur (1), avec lequel l'action de l'utilisateur est exécutée.
  3. Procédé selon l'une des revendications précédentes, dans lequel l'action de l'utilisateur comprend au moins une mise en service du respirateur (1) et de préférence aussi au moins une saisie dans le respirateur (1).
  4. Procédé selon l'une des revendications précédentes, dans lequel l'action de l'utilisateur comprend au moins un enregistrement biométrique de l'utilisateur et/ou au moins une commande vocale et/ou au moins une connexion du respirateur (1) avec au moins un support de stockage (41).
  5. Procédé selon l'une des revendications précédentes, dans lequel le code d'autorisation sollicité est indiqué à l'utilisateur sur au moins un afficheur (11) et/ou est enregistré sur au moins un support de stockage (41).
  6. Procédé selon l'une des revendications précédentes, dans lequel l'action de l'utilisateur comprend au moins un enregistrement de l'utilisateur auprès du dispositif de traitement de données (2), de préférence auprès du poste terminal (3), de sorte que seul un utilisateur enregistré peut solliciter le code d'autorisation.
  7. Procédé selon la revendication précédente, dans lequel au moins un certificat est attribué à l'utilisateur lors de l'enregistrement et dans lequel le certificat doit être soumis au respirateur (1) pour pouvoir solliciter le code d'autorisation.
  8. Procédé selon la revendication précédente, dans lequel le certificat est enregistré sur un support de stockage transportable (41) et dans lequel le code d'autorisation ne peut être sollicité que si le respirateur (1) est connecté au support de stockage (41).
  9. Procédé selon la revendication précédente, dans lequel au moins un certificat d'appareil identifiant le respirateur (1) est aussi enregistré sur le support de stockage (41) par le poste terminal (3) en plus du certificat.
  10. Procédé selon l'une des trois revendications précédentes, dans lequel le code d'autorisation est généré au moins en partie par le respirateur (1) compte tenu du certificat.
  11. Procédé selon la revendication 6, dans lequel l'accès aux données thérapeutiques est débloqué, si l'utilisateur enregistré se connecte au poste terminal (3), après qu'il a sollicité au préalable le code d'autorisation en tant qu'utilisateur enregistré ou si l'utilisateur communique le code d'autorisation mis à sa disposition au poste terminal (3).
  12. Procédé selon la revendication précédente, dans lequel le code d'autorisation est saisi par l'utilisateur dans le poste terminal (3) ou le respirateur (1) transmet le code d'autorisation au moins en partie de façon autonome au poste terminal (3).
  13. Procédé selon l'une des revendications précédentes, dans lequel le code d'autorisation comprend au moins un numéro de série et/ou au moins un numéro d'identification du respirateur (1) ou est généré au moins en partie à partir de ceux-ci.
  14. Procédé selon l'une des revendications précédentes, dans lequel le code d'autorisation comprend au moins une information relative à une autorisation de l'utilisateur quant à l'accès aux données thérapeutiques et/ou au moins une information relative au moins à un droit de lecture et/ou à un droit d'écriture de l'utilisateur.
  15. Procédé selon l'une des revendications précédentes, dans lequel le code d'autorisation présente au moins une validité limitée dans le temps et/ou une validité unique.
  16. Procédé selon la revendication précédente, dans lequel la validité du code d'autorisation est liée à l'utilisateur ou la validité du code d'autorisation est annulée, si le respirateur (1) est employé pour un nouveau patient.
  17. Procédé selon l'une des revendications précédentes, dans lequel le code d'autorisation, lequel est sollicité par l'utilisateur, est enregistré au moins en partie dans le respirateur (1) et/ou est généré au moins en partie par le respirateur (1).
  18. Procédé selon l'une des revendications précédentes, dans lequel au moins une partie du code d'autorisation, lequel est sollicité par l'utilisateur, est générée et/ou enregistrée dans l'espace séparément du respirateur (1), en particulier dans le poste terminal (3).
  19. Système de ventilation (10) comprenant au moins un respirateur (1) avec au moins un dispositif de ventilation (100) pour générer un flux d'air destiné à une thérapie respiratoire et au moins un poste terminal (3) séparé spatialement du respirateur (1) et au moins un dispositif de traitement de données (2), dans lequel le dispositif de traitement de données (2) permet de transmettre des données thérapeutiques entre le respirateur (1) et le poste terminal (3) et dans lequel au moins un code d'autorisation peut être enregistré dans le dispositif de traitement de données (2) pour accorder un accès autorisé aux données thérapeutiques à un utilisateur via le poste terminal (3), et dans lequel le dispositif de traitement de données (2) est apte et conçu de manière à mettre le code d'autorisation à la disposition de l'utilisateur lorsque ce dernier sollicite le code d'autorisation par une action de l'utilisateur à accomplir auprès du dispositif de traitement de données (2).
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HK1256229A1 (zh) 2019-09-20
EP3340095A1 (fr) 2018-06-27
US20180182473A1 (en) 2018-06-28
DE102017011812A1 (de) 2018-06-28
CN108236749A (zh) 2018-07-03
CN108236749B (zh) 2022-06-07

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